Digitalising QA & Data Integrity in Aseptic Manufacturing

Context

Auditability and data integrity are mission-critical in aseptic manufacturing. The organisation needed consistent audit trail review, clearer data flows between systems, and fewer spreadsheet-driven QA processes. Multiple sites, varied system maturity, and strict validation standards made execution difficult.

Initiatives

• Audit Trail Review (Phase 1 & 2): scoped GxP-relevant systems, aligned risk-based review frequency, and created templates and SOP-aligned guidance. Built overviews so QA and management could track completion, open findings, and support needs across sites.
• Data flow risk assessments: mapped how data moved between systems, identified integrity gaps, and prioritised mitigations that fed into future digital solutions.
• Digital QA tools: delivered Power Apps and Power Automate flows for QA workflows, plus ServiceNow dashboards for QA oversight of incidents, changes, and configuration on GxP systems.
• Reporting & visibility: built Power BI/Tableau views of quality KPIs so oversight moved from email summaries to live dashboards.
• Governance & lifecycle: outlined a pragmatic development lifecycle (idea → analysis → build → test → release → operate) that keeps Agile iterations aligned with validation expectations; refreshed SharePoint IA to make digital QA work and governance discoverable.

Impact

• Harmonised, risk-based ATR practices with clear ownership between QA, IT, and system managers.
• Reduced manual QA admin through structured apps and automated routing/reminders.
• Better inspection readiness via consistent evidence and dashboards instead of scattered files.
• Reusable patterns for Agile-but-compliant delivery on Power Platform and ServiceNow.